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10 NON-REACTIVE: One blue dot, clearly discernible above any background tint on the membrane. This is the IgG Control Spot: shows test has been performed correctly and sample has been added. The control is located towards the top of the read frame, furthest from the plastic tab on the Membrane Unit. No reaction should be visible at the test spot, located below the control. This result indicates antibodies to HIV-1/HIV-2 were not detected. INSTI Interpretation CONTROL TAB

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11 INSTI Interpretation…2 REACTIVE: Two blue dots discernible above any background tint indicate possible presence of HIV-1/HIV-2 antibodies. One dot may be darker than the other. A sample giving this pattern is considered a preliminary reactive. Following a reactive rapid test result, a venous blood sample must be drawn for laboratory-based confirmatory testing. TEST CONTROL TAB CONTROL TEST TAB TEST CONTROL TAB

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12 TAB TAB TEST A.There is no dot on the membrane INVALID results : B.The test dot appears without the control dot Recommendation: INVALID tests with finger- stick blood samples in POC settings should be repeated with a fresh sample using a new membrane unit, kit components, and support materials. INSTI Interpretation…3

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13 TAB TEST CONTROL The test is INDETERMINATE if a faint background ring appears on the test area. Following an indeterminate test result, a venous blood sample must be drawn in an EDTA collection tube (for whole blood or plasma) or red-top tube (for serum), and forwarded to a laboratory for HIV confirmatory testing. INDETERMINATE: INSTI Interpretation…4

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15 Objective To evaluate the efficacy of HIV POC testing at Hassle Free Clinic To set standards of care for HIV POC testing To monitor client uptake and satisfaction To evaluate provider satisfaction

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23 Conclusions Based on HFC experience and INSTI HIV performance, the MOH is expanding rapid HIV POC testing to 60 anonymous HIV and sexual health clinics in Ontario Implementation includes new counseling guidelines, training for providers, rigorous quality assurance policies and procedures including kit controls and external quality assessment, and a system to collect epi data on all testers. Anticipated volume – 60,000 tests per year